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'First oral drug' for type 1 diabetes shows promise in phase III trial

Sotagliflozin has the potential to become the first oral medication to be approved for the treatment of type 1 diabetes, and the first new innovative treatment for the condition since insulin was discovered more than a century ago.

An investigational new oral drug for type 1 diabetes has shown promise in improving glucose control when used in conjunction with insulin, compared with using insulin alone[1].

According to the authors of the study (13 September 2017) no oral medication has been approved for use in combination with insulin to lower the glucose level in patients with type 1 diabetes, so sotagliflozin has the potential to become the first new treatment innovation for the condition since insulin was discovered more than a century ago.

The double-blind, randomised control trial comprised 1,402 trial participants with type 1 diabetes who were assigned to either 400mg of sotagliflozin or placebo, to be taken daily alongside their insulin therapy.

At week 24, the results showed that a significantly larger proportion of patients taking the active drug, which works by inhibiting two sodium-glucose transporters, achieved the primary end point of a glycated haemoglobin level lower than 7% and no episodes of severe hypoglycaemia or diabetic ketoacidosis.

The use of sotagliflozin was also associated with significant decreases in fasting plasma glucose level, insulin dose, weight and systolic blood pressure.

However, the research also found that rates of diabetic ketoacidosis and hypoglycaemia were higher among patients who received sotagliflozin but did not achieve the target glycated haemoglobin level than in the placebo group.

“Sotagliflozin added to insulin therapy can potentially help patients with type 1 diabetes improve their glucose control and hopefully manage the disease with fewer complications,” said Satish Garg, professor of medicine and paediatrics for the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus and lead author of the study.

“This would not be a replacement for insulin; it is an adjunctive therapy. However, because it works in the gut and the kidneys, it doesn’t require insulin to have an effect.”

The researchers said that the trial had some limitations however, primarily because the long-term effects of sotagliflozin cannot be determined in 24 weeks.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203587

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